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Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
This study has been completed.
First Received: April 7, 2003   Last Updated: July 20, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057759
  Purpose

RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life.

PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.


Condition Intervention
Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexual Dysfunction and Infertility
Sexuality and Reproductive Issues
 Drug: sildenafil citrate

Study Type: Interventional
Study Design: Supportive Care, Randomized, Placebo Control
Official Title: Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life

Resource links provided by NLM:

MedlinePlus related topics: Cancer Erectile Dysfunction Infertility Prostate Cancer
Drug Information available for: Sildenafil Sildenafil citrate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2003
Detailed Description:

OBJECTIVES:

  • Compare the effect of sildenafil vs placebo on erectile dysfunction in patients with prostate cancer treated with radiotherapy and antiandrogens on RTOG-9910.
  • Compare the overall sexual function and satisfaction of patients treated with these regimens.
  • Compare sexual satisfaction of partners of patients treated with these regimens.
  • Compare patient and partner marital adjustment after treatment with these regimens.
  • Determine factors that may predict response to sildenafil, including age, pretreatment sexual function, tobacco use, and comorbidities in these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to prior use of sildenafil after treatment on RTOG-9910 and level of response (No vs yes [unsatisfactory] vs yes [satisfactory]), International Index of Erectile Function Question #1 score (0-1 vs 2-3), and RTOG-9910 treatment arm (I vs II). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral sildenafil 1 hour prior to desired sexual intercourse.
  • Arm II: Patients receive oral placebo 1 hour prior to desired sexual intercourse.

Treatment on both arms continues for 12 weeks. Patients then cross over to treatment on the other arm for 12 weeks.

Quality of life, including sexual function, marital adjustment, and partner's satisfaction, is assessed at baseline, at 12 and 25 weeks, and at 1 year.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Prior treatment on RTOG-9910 for intermediate relapse-risk stage II or III prostate cancer as determined by any of the following combinations of factors:

    • T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 ng/mL but no greater than 100 ng/mL
    • T1b-4, Gleason score 7, and PSA less than 20 ng/mL
    • T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL
  • Radiotherapy completed within the past 6 months to 5 years

  • Pretreatment (before enrollment on this study) erectile dysfunction as measured by International Index of Erectile Function Question #1

    • Erectile dysfunction before starting prostate cancer therapy allowed
  • Patients without partners or without partners willing to participate allowed

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Cardiovascular

  • No myocardial infarction within the past year

Other

  • No other invasive cancer within the past 5 years except localized basal cell or squamous cell skin cancer (stage 0-II)
  • No anatomical genital abnormalities or concurrent conditions that would prohibit sexual intercourse or preclude study participation
  • No other major medical or psychiatric illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • More than 6 months since prior androgen suppression (e.g., leuprolide or goserelin), antiandrogen (e.g., bicalutamide, flutamide, or nilutamide), or estrogenic (e.g., diethylstibestrol) agents

Radiotherapy

  • See Disease Characteristics

Surgery

  • No prior penile implant
  • No prior bilateral orchiectomy

Other

  • No concurrent sildenafil
  • No concurrent participation in another medical research study to treat prostate cancer
  • No concurrent organic nitrate or requirement for nitrates (e.g., nitroglycerin as needed)
  • No concurrent ketoconazole, itraconazole, or erythromycin
  • No concurrent use of mechanical (vacuum) devices or intracorporeal, intraurethral, topical, or oral agents for erectile dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057759

  Show 30 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Deborah Watkins Bruner, RN, PhD Fox Chase Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Bruner DW, James J, Pisansky TM, et al.: RTOG 0215 treatment of erectile dysfunction (ED) in patients treated with neoadjuvant and concurrent androgen deprivation (AD) and radiotherapy (RT) for prostate cancer (PC). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-52, S30, 2007.

Study ID Numbers: CDR0000269135, RTOG-0215, NCI-P-02-0234
Study First Received: April 7, 2003
Last Updated: July 20, 2009
ClinicalTrials.gov Identifier: NCT00057759     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
sexual dysfunction and infertility
sexuality and reproductive issues
radiation toxicity
 stage II prostate cancer
stage III prostate cancer
psychosocial effects of cancer and its treatment

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Infertility
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Enzyme Inhibitors
Sildenafil
Urogenital Neoplasms
Cardiovascular Agents
Genital Diseases, Male
 Sexual and Gender Disorders
Pharmacologic Actions
Genital Diseases, Female
Neoplasms
Phosphodiesterase Inhibitors
Neoplasms by Site
Sexual Dysfunction, Physiological
Mental Disorders
Therapeutic Uses
Prostatic Neoplasms
Erectile Dysfunction

ClinicalTrials.gov processed this record on November 09, 2009



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